Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver (SONAR: Surgery in Oligometastatic PaNcreatic CAnceR) a Randomized Controlled Trial
This study investigates the impact of surgical resection compared to palliative care in patients with oligometastatic pancreatic cancer limited to the liver. Specifically, it examines whether surgery after stable disease or response to chemotherapy can improve survival and quality of life. The international, multicenter randomized trial will recruit 56 patients, assigning them to either surgical resection (including tumor and liver metastases) or ongoing palliative care with chemotherapy. Stratification by performance status, tumor markers, and tumor location will ensure balanced study groups. Outcome assessments, conducted over a minimum two-year follow-up, include clinical evaluations, imaging, and quality-of-life metric
• Adult patients aged ≥18 years and ≤75 years (at diagnosis).
• Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5).
• Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions).
• No evidence of extrahepatic metastases (at diagnosis.)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment)
• Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment).
• Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment).
• Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation/microwave once no larger than 20 mm (at enrollment).